Project description:BackgroundThe radioactive seed localization (RSL) is used in impalpable breast cancer conservative surgery to assist the surgeon in accurately locating and excising the lesion site. This study aims to present recommendations about the RSL program implementation in health institutions that perform breast cancer conservative surgery with intraoperative localization.MethodsAn extensive literature review was performed. It comprehends: the committee responsible for implementation of the program actions; description of the necessary multidisciplinary team; the radiological safety committee role; the facility licensing; professionals training; material and instrumentation associated with the technique; and seed tracking system.Results13 topics are presented. The Program Implementation Committee must be formed by leaders from each department. The committee assumes responsibility for evaluating the necessary processes and presenting the schedule for program implementation. Since the procedure is classified as a nuclear medicine procedure it requires licensing. The Professional Team Formation, Education, and Training is a priority and simulation exercises are necessary. The Materials and Instrumentation Associated with the Technique must be well-know by the team and they should practice using radiation detectors. The seed must be always tracked, from moment they are received to discard. An Inventory for Tracking Seeds is provided. The Radiological Safety Aspects such as the ALARA principle are presented. A full description for the Radiological Procedure for Placing the seeds, the surgical removal and the Specimen Handling in Pathology focusing on how to locate the seed and retrieve them. After removed, the seeds can be placed in storage to wait for full radioactive decay or be returned to the manufacturer.ConclusionsThe procedure has the advantage to increase to 2 months the time between insertion of the seed and the surgical removal. Regular multidisciplinary team meetings during program development are important to create a realistic timeline, having briefing meetings after the first 1-5 RSL cases and having annual or biannual follow-up meetings to discuss any issues or incidents. Abstract Graphic ImageCreated by Macrovector, obtained in Freepik at https://br.freepik.com/fotos-vetores-gratis/oncologia.This graphical abstract shows everything that is necessary to implement the RSL technique and are discussed in this paper.HighlightsThis study present recommendations for RSL program implementation in hospitalsWas performed by an extensive descriptive and qualitative literature reviewTopics 1: Implementation Committee, Professional Team Training, InstrumentationTopics 2: Radiological Safety, Patient Consent, Radiological ProcessTopics 3: Surgical Procedure, Pathology, Seeds Disposal Completion.
Project description:BackgroundMost breast cancers are detected at an early stage in which case conservative surgery is indicated. An accurate preoperative localization technique is essential for conservative surgery of non-palpable breast lesions. Currently, the gold standard technique is wire localization (WL). However, this technique has well-known drawbacks. Several wire-free techniques have been developed to overcome these drawbacks; one technique is localisation by Radiofrequency Identification (RFID). The purpose of this clinical trial was to assess the superiority of RFID tags (HOLOGIC) in terms of patient satisfaction, over wire localization of non-palpable breast lesions.MethodsThis was a single-centre, prospective, controlled and non-interventional trial. Patients were followed from their inclusion at the time of the preoperative consultation to the postoperative consultation, one month after surgery. Data on anxiety and satisfaction was collected from patients and clinicians using questionnaires, and clinical data was collected from the medical files. The primary outcome was the patients' satisfaction scores, assessed using a visual analogue scale.ResultsEighty patients were sequentially enrolled in two groups: the wire group (n = 40) and the RFID group (n = 40). One patient from the RFID group was excluded from the analysis because of a substantial migration during deployment. On a 10-point Visual Analogue Scale, the patients' median satisfaction score was 9.8 (IQR = 1.32) for the wire group and 10 (IQR = 0.07) for the RFID group (p < 0.001). A reduction in pain between device insertion and surgery was observed in the RFID group (p = 0.009). The median placement time was shorter in the RFID group (15 min, IQR = 6) than in the wire group (20 min, IQR = 30) (p = 0.01).ConclusionOur results show a statistically significant difference in median patient satisfaction score with the localization of non-palpable breast cancer lesions using RFID tags compared to the use of the WL. Although our results did not show clinically significant outcomes in terms of satisfaction, RFID tags are a reliable alternative to WL and simplify the organization of patients' healthcare trajectories.Trial registrationClinicalTrials.gov ID; NCT04750889 registered on February 11, 2021. https://clinicaltrials.gov/ct2/show/NCT04750889?term=rfid&draw=2&rank=1.
Project description:BackgroundThere is little literature comparing intraoperative ultrasound (IOUS) with radio-guided occult lesions localization (ROLL) in nonpalpable invasive tumors in breast conserving surgery (BCS). There is a need to compare these two methods in terms of safety and efficacy.MethodsThis is an observational cohort study. All patients treated with BCS for nonpalpable invasive breast cancer using IOUS from March 2016 to March 2020 were included and compared with a historical reference control group operated on using ROLL from March 2013 to March 2017. For each detection method, the ability to locate tumors intraoperatively, tumor and surgical specimen sizes, total resection volume (TRV), optimal resection volume, excess of healthy tissue resected (ETR), margin status, re-excision rate, surgical time, complications and costs were studied.ResultsOne hundred and fifty-eight were included, 83 with IOUS and 75 with ROLL. The mean tumor size is equivalent in both groups (11.88 mm IOUS vs. 12.29 mm ROLL, P=0.668). TRV is significantly lower with IOUS (24.92 vs. 60.32 cm3, P<0.001), and the ETR is also significantly lower in the IOUS group (21.74 vs. 58.37 cm3, P<0.001). The rate of positive margins did not differ (10.98% vs. 12.16%, P=1), nor did re-excision rate (10.98% vs. 8.11%, P=0.597). Complication rate did not differ (12.2% IOUS vs. 10.81% ROLL, P=0.808). Surgical time was shorter in IOUS (45.5 vs. 57 min, P>0.05).ConclusionsIOUS in BCS for nonpalpable invasive breast cancer is more accurate than ROLL because it decreases excision volumes with the same rate of free margins and re-excision. Also, IOUS is a more efficient and comfortable technique, and just as safe as ROLL.
Project description:Breast cancer diagnosis and staging is based on mammography, ultrasound, and magnetic resonance imaging (MRI). Contrast enhanced spectral mammography (CESM) has gained momentum as an innovative and clinically useful method for breast assessment. CESM is based on abnormal enhancement of neoplastic tissue compared to surrounding breast tissue. We performed a systematic review of prospective trial to evaluate its diagnostic performance, following standard PRISMA-DTA. We used a bivariate random-effects regression approach to obtain summary estimates of both sensitivity and specificity of CESM. 8 studies published between 2003 and 2019 were included in the meta-analysis for a total of 945 lesions. The summary area under the curve obtained from all the study was 89% [95% CI 86%-91%], with a sensitivity of 85% [95% CI 73%-93%], and a specificity of 77% [95% CI 60%-88%]. With a pre-test probability of malignancy of 57% a positive finding at CESM gives a post-test probability of 83% while a negative finding a post-test probability of 20%. CESM shows a suboptimal sensitivity and specificity in the diagnosis of breast cancer in a selected population, and at present time, it could be considered only as a possible alternative test for breast lesions assessment when mammography and ultrasound are not conclusive or MRI is contraindicated or not available.
Project description:AimWe performed a systematic review and meta-analysis to evaluate the efficacy and safety of microwave ablation (MWA) for benign breast lesions.Material and methodsPubMed, Embase, Web of Science, Cochrane Library databases, China National Knowledge Infrastructure, and Wanfang Data Knowledge Service Platform databases were searched.ResultsA total of 10 studies were included, giving a sample size of 1241 patients and 2729 benign breast lesions. The first complete ablation success rate was 96%. The volume reduction ratio (VRR) after 3/6/12 months was 47.4%, 62.1%, and 85.8%, respectively. After 12 months, the lesion disappearance rate was 53.6%, and the efficiency rate was 99%. The rate of excellent cosmesis was 88% and the rate of good cosmesis was 10%. The complication rate was 2%.ConclusionsMWA is safe and effective for treating benign breast lesions. It can be a promising minimally invasive choice for benign breast lesions.
Project description:ImportanceWhether radioactive iodine (RAI) therapy for hyperthyroidism can increase cancer risk remains a controversial issue in medicine and public health.ObjectivesTo examine site-specific cancer incidence and mortality and to evaluate the radiation dose-response association after RAI treatment for hyperthyroidism.Data sourcesThe Medline and Cochrane Library electronic databases, using the Medical Subject Headings terms and text keywords, and Embase, using Emtree, were screened up to October 2020.Study selectionStudy inclusion criteria were as follows: (1) inclusion of patients treated for hyperthyroidism with RAI and followed up until cancer diagnosis or death, (2) inclusion of at least 1 comparison group composed of individuals unexposed to RAI treatment (eg, the general population or patients treated for hyperthyroidism with thyroidectomy or antithyroid drugs) or those exposed to different administered doses of RAI, and (3) inclusion of effect size measures (ie, standardized incidence ratio [SIR], standardized mortality ratio [SMR], hazard ratio [HR], or risk ratio [RR]).Data extraction and synthesisTwo independent investigators extracted data according to the Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines. Overall quality assessment followed the recommendations of United Nations Scientific Committee on the Effects of Atomic Radiation. The SIR and SMRs and the RRs and HRs were pooled using random-effects meta-analysis.Main outcomes and measuresCancer incidence and mortality for exposure vs nonexposure to RAI therapy and by level of RAI administered activity.ResultsBased on data from 12 studies including 479 452 participants, the overall pooled cancer incidence ratio was 1.02 (95% CI, 0.95-1.09) and the pooled cancer mortality ratio was 0.98 (95% CI, 0.92-1.04) for exposure vs nonexposure to RAI therapy. No statistically significant elevations in risk were observed for specific cancers except thyroid cancer incidence (SIR, 1.86; 95% CI, 1.19-2.92) and mortality (SMR, 2.22; 95% CI, 1.37-3.59). However, inability to control for confounding by indication and other sources of bias were important limitations of studies comparing RAI exposure with nonexposure. In dose-response analysis, RAI was significantly associated with breast and solid cancer mortality (breast cancer mortality, per 370 MBq: 1.35; P = .03; solid cancer mortality, per 370 MBq: 1.14; P = .01), based on 2 studies.Conclusions and relevanceIn this meta-analysis, the overall pooled cancer risk after exposure to RAI therapy vs nonexposure was not significant, whereas a linear dose-response association between RAI therapy and solid cancer mortality was observed. These findings suggest that radiation-induced cancer risks following RAI therapy for hyperthyroidism are small and, in observational studies, may only be detectable at higher levels of administered dose.
Project description:BackgroundIn recent years there has been an increasing interest in MRI as a non-invasive diagnostic modality for the work-up of suspicious breast lesions. The additional value of Breast MRI lies mainly in its capacity to detect multicentric and multifocal disease, to detect invasive components in ductal carcinoma in situ lesions and to depict the tumor in a 3-dimensional image. Breast MRI therefore has the potential to improve the diagnosis and provide better preoperative staging and possibly surgical care in patients with breast cancer. The aim of our study is to assess whether performing contrast enhanced Breast MRI can reduce the number of surgical procedures due to better preoperative staging and whether a subgroup of women with suspicious nonpalpable breast lesions can be identified in which the combination of mammography, ultrasound and state-of-the-art contrast-enhanced Breast MRI can provide a definite diagnosis.Methods/designThe MONET - study (MR mammography Of Nonpalpable BrEast Tumors) is a randomized controlled trial with diagnostic and therapeutic endpoints. We aim to include 500 patients with nonpalpable suspicious breast lesions who are referred for biopsy. With this number of patients, the expected 12% reduction in surgical procedures due to more accurate preoperative staging with Breast MRI can be detected with a high power (90%). The secondary outcome is the positive and negative predictive value of contrast enhanced Breast MRI. If the predictive values are deemed sufficiently close to those for large core biopsy then the latter, invasive, procedure could possibly be avoided in some women. The rationale, study design and the baseline characteristics of the first 100 included patients are described.Trial registrationStudy protocol number NCT00302120.
Project description:BackgroundWire localization is historically the most common method for guiding excision of non-palpable breast lesions, but there are limitations to the technique. Newer technologies such as magnetic seeds may allow some of these challenges to be overcome. The aim was to compare safety and effectiveness of wire and magnetic seed localization techniques.MethodsWomen undergoing standard wire or magnetic seed localization for non-palpable lesions between August 2018 and August 2020 were recruited prospectively to this IDEAL stage 2a/2b platform cohort study. The primary outcome was effectiveness defined as accurate localization and removal of the index lesion. Secondary endpoints included safety, specimen weight and reoperation rate for positive margins.ResultsData were accrued from 2300 patients in 35 units; 2116 having unifocal, unilateral breast lesion localization. Identification of the index lesion in magnetic-seed-guided (946 patients) and wire-guided excisions (1170 patients) was 99.8 versus 99.1 per cent (P = 0.048). There was no difference in overall complication rate. For a subset of patients having a single lumpectomy only for lesions less than 50 mm (1746 patients), there was no difference in median closest margin (2 mm versus 2 mm, P = 0.342), re-excision rate (12 versus 13 per cent, P = 0.574) and specimen weight in relation to lesion size (0.15 g/mm2versus 0.138 g/mm2, P = 0.453).ConclusionMagnetic seed localization demonstrated similar safety and effectiveness to those of wire localization. This study has established a robust platform for the comparative evaluation of new localization devices.
Project description:BACKGROUND: Currently employed techniques for the localization of nonpalpable breast lesions suffer from various limitations. In this paper, we report on 2 patients in order to introduce an alternative technique, indocyanine green fluorescence-guided occult lesion localization (IFOLL), and determine its applicability for the surgical removal of this type of breast lesions. CASE REPORTS: Preoperatively, one of the patients had a needle biopsy-proven diagnosis of breast cancer, and the other one had suspicious findings for malignancy. Lesion localization was performed within 1 h before surgery under ultrasonography control by injecting 2 ml and 0.2 ml of indocyanine green into the lesion and its subcutaneous tissue projection, respectively. During surgery, the site of skin incision and the resection margins were identified by observing the area of indocyanine-derived fluorescence under the guidance of a near-infrared-sensitive camera. In both cases, the breast lesion was correctly localized, and the area of fluorescence corresponded well to the site of the lesions. Subsequent surgical excision was successful with no complications. On histopathologic examination, the surgical margins were found to be clear. CONCLUSION: IFOLL seems to be a technically applicable and clinically acceptable procedure for the removal of nonpalpable breast cancer.